Premium
Efficacy of tacrolimus 0.03% ointment as second‐line treatment for children with moderate‐to‐severe atopic dermatitis: evidence from a randomized, double‐blind non‐inferiority trial vs. fluticasone 0.005% ointment
Author(s) -
Doss N.,
Kamoun M.R.,
Dubertret L.,
Cambazard F.,
Remitz A.,
Lahfa M.,
De Prost Y.
Publication year - 2010
Publication title -
pediatric allergy and immunology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.269
H-Index - 89
eISSN - 1399-3038
pISSN - 0905-6157
DOI - 10.1111/j.1399-3038.2009.00895.x
Subject(s) - medicine , tacrolimus , atopic dermatitis , fluticasone , dermatology , randomized controlled trial , double blind , corticosteroid , placebo , alternative medicine , transplantation , pathology
Doss N, Kamoun M‐R, Dubertret L, Cambazard F, Remitz A, Lahfa M, de Prost Y. Efficacy of tacrolimus 0.03% ointment as second‐line treatment for children with moderate‐to‐severe atopic dermatitis: evidence from a randomized, double‐blind non‐inferiority trial vs. fluticasone 0.005% ointment.
Pediatr Allergy Immunol 2010: 21: 321–329.
© 2009 John Wiley & Sons A/S Tacrolimus 0.03% ointment is licensed for second‐line treatment of children with atopic dermatitis (AD). Although data are available from clinical trials, no study has enrolled only second‐line patients. This double‐blind, non‐inferiority study compared tacrolimus 0.03% and fluticasone 0.005% ointments in children with moderate‐to‐severe AD, who had responded insufficiently to conventional therapies. Children (aged 2–15 yr) were randomized to tacrolimus ointment (n = 240) or fluticasone ointment (n = 239), twice daily until clearance or for a maximum of 3 wk and, if lesions remained, once daily for up to 3 wk further. Primary end‐point was week 3 response rate (improvement of ≥60% in modified Eczema Area and Severity Index and not withdrawn for lack of efficacy). Secondary end‐points included pruritus and sleep quality, global assessment of clinical response, incidence of new flares and safety. Response rates were 86.3% with tacrolimus ointment and 91.5% with fluticasone. Lower limit of the 95% confidence interval was −11.8%, exceeding the non‐inferiority limit of −15% and meeting the primary end‐point. Moderate or better improvement on the physicians’ global assessment occurred in 93.6% and 92.4% of patients in the tacrolimus ointment and fluticasone arms, respectively, while median pruritus scores improved by 84.0% and 91.5%. Sleep quality improved by approximately 92% in both treatment arms. After day 21, new flare‐up occurred in 5.5% and 11.3% of patients receiving tacrolimus ointment and fluticasone, respectively; mean times to new flares were 6.5 ± 5.0 and 8.6 ± 5.2 days. Adverse events were similar between the two arms, with the exception of application‐site skin burning sensation in the tacrolimus ointment group. In conclusion, efficacy of tacrolimus 0.03% ointment as second‐line treatment was not inferior to that of fluticasone 0.005% ointment, with similar benefits on global disease improvement and quality of sleep.